FDA UDI
In Commercial Distribution
🇺🇸 United States
Assura
DI: 00762123033739
·
Model: 12176
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Assura
- Primary DI
- 00762123033739
- Version / Model
- 12176
- Catalog Number
- 12176
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 3
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- a9802070-cd34-412b-a79f-8dfefd502a8b
Device Description
Alterna Flex ostomy bag / Assura Flex ostomy bag. Base Plate Precut Start Hole Size 35 mm, Base Plate Type Flat.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXB | COLLECTOR, OSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31066 | One-piece intestinal ostomy bag, closed-ended | A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00762123034033 | GS1 | Shipper Box | 16 | In Commercial Distribution | |
| Primary | 00762123033739 | GS1 | ||||
| Unit of Use | 05701780084888 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Descriptive Bag Size Maxi | ||
| Device Size Text, specify | Base Plate Precut Start Hole Size - mm 35 | ||
| Device Size Text, specify | Base Plate Precut Start Hole Size - in 1 3/8 | ||
| Device Size Text, specify | Base Plate Type Flat |